82 FR 27266 - Determination of Regulatory Review Period for Purposes of Patent Extension; NEUROPACE RNS SYSTEM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 113 (June 14, 2017)

Page Range		27266-27268
FR Document		2017-12322

The Food and Drug Administration (FDA) has determined the regulatory review period for NEUROPACE RNS SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

Federal Register, Volume 82 Issue 113 (Wednesday, June 14, 2017)

[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27266-27268]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-12322]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-0635; FDA-2015-E-0634; FDA-2015-E-0629]

Determination of Regulatory Review Period for Purposes of Patent
Extension; NEUROPACE RNS SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for NEUROPACE RNS SYSTEM and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that medical
device.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
14, 2017. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by December 11, 2017.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be

[[Page 27267]]

considered. Electronic comments must be submitted on or before August
14, 2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of August 14,
2017. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2015-E-0635, FDA-2015-E-0634, and FDA-2015-E-0629 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; NEUROPACE RNS SYSTEM.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the dockets and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background

The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device NEUROPACE RNS
SYSTEM. NEUROPACE RNS SYSTEM is indicated as an adjunctive therapy in
reducing the frequency of seizures in individuals 18 years of age or
older with partial onset seizures who have undergone diagnostic testing
that localized no more than 2 epileptogenic foci, are refractory to two
or more antiepileptic medications, and currently have frequent and
disabling seizures (motor partial seizures, complex partial seizures,
and/or secondarily generalized seizures). Subsequent to this approval,
the USPTO received patent term restoration applications for NEUROPACE
RNS SYSTEM (U.S. Patent Nos. 6,016,449; 6,360,122; and 6,810,285) from
NeuroPace, Inc., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated November 2, 2015, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of NEUROPACE RNS SYSTEM represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

[[Page 27268]]

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for
NEUROPACE RNS SYSTEM is 3,796 days. Of this time, 2,694 days occurred
during the testing phase of the regulatory review period, while 1102
days occurred during the approval phase. These periods of time were
derived from the following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: June 26, 2003. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective was June 26, 2003.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): November
9, 2010. FDA has verified the applicant's claim that the premarket
approval application (PMA) for NEUROPACE RNS SYSTEM (PMA P100026) was
initially submitted November 9, 2010.
3. The date the application was approved: November 14, 2013. FDA
has verified the applicant's claim that PMA P100026 was approved on
November 14, 2013.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
the applicant seeks 5 years of patent term extension.

III. Petitions

Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES and
ADDRESSES) and contain sufficient facts to merit an FDA investigation.
(See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.)
Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12322 Filed 6-13-17; 8:45 am]
BILLING CODE 4164-01-P

27266 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices

Dated: June 9, 2017. Hampshire Ave., Bldg. 66, Rm. G616, advisory committee for which the
Anna K. Abram, Silver Spring, MD 20993, 301–796– nominee is recommended. Nominations
Deputy Commissioner for Policy, Planning, 7047, email: Sara.Anderson@ must also acknowledge that the
Legislation, and Analysis. fda.hhs.gov. nominee is aware of the nomination
[FR Doc. 2017–12326 Filed 6–13–17; 8:45 am] SUPPLEMENTARY INFORMATION: FDA is unless self-nominated. FDA will ask
BILLING CODE 4164–01–P requesting nominations for voting potential candidates to provide detailed
members on the National information concerning such matters
Mammography Quality Assurance related to financial holdings,
DEPARTMENT OF HEALTH AND Advisory Committee. employment, and research grants and/or
HUMAN SERVICES contracts to permit evaluation of
I. General Description of the Committee possible sources of conflict of interest.
Food and Drug Administration Duties This notice is issued under the
[Docket No. FDA–2017–N–0001] The National Mammography Quality Federal Advisory Committee Act (5
Assurance Advisory Committee advises U.S.C. app. 2) and 21 CFR part 14,
Request for Nominations of Voting the Commissioner of Food and Drugs relating to advisory committees.
Members on a Public Advisory (the Commissioner) or designee on: (1) Dated: June 9, 2017.
Committee; National Mammography Developing appropriate quality Anna K. Abram,
Quality Assurance Advisory standards and regulations for
Deputy Commissioner for Policy, Planning,
Committee mammography facilities; (2) developing Legislation, and Analysis.
appropriate standards and regulations
AGENCY: Food and Drug Administration, [FR Doc. 2017–12312 Filed 6–13–17; 8:45 am]
for bodies accrediting mammography
HHS. facilities under this program; (3) BILLING CODE 4164–01–P
ACTION: Notice. developing regulations with respect to
sanctions; (4) developing procedures for
SUMMARY: The Food and Drug DEPARTMENT OF HEALTH AND
monitoring compliance with standards;
Administration (FDA) is requesting HUMAN SERVICES
(5) establishing a mechanism to
nominations for voting members to
investigate consumer complaints; (6) Food and Drug Administration
serve on the National Mammography
reporting new developments concerning
Quality Assurance Advisory Committee [Docket Nos. FDA–2015–E–0635; FDA–
breast imaging that should be
in the Center for Devices and 2015–E–0634; FDA–2015–E–0629]
considered in the oversight of
Radiological Health. FDA seeks to
mammography facilities; (7)
include the views of women and men, Determination of Regulatory Review
determining whether there exists a
members of all racial and ethnic groups, Period for Purposes of Patent
shortage of mammography facilities in
and individuals with and without Extension; NEUROPACE RNS SYSTEM
rural and health professional shortage
disabilities on its advisory committees areas and determining the effects of AGENCY: Food and Drug Administration,
and, therefore, encourages nominations personnel on access to the services of HHS.
of appropriately qualified candidates such facilities in such areas; (8)
from these groups. ACTION: Notice.
determining whether there will exist a
DATES: Nominations received on or sufficient number of medical physicists SUMMARY: The Food and Drug
before August 14, 2017, will be given after October 1, 1999; and (9) Administration (FDA) has determined
first consideration for membership on determining the costs and benefits of the regulatory review period for
the National Mammography Quality compliance with these requirements. NEUROPACE RNS SYSTEM and is
Assurance Advisory Committee. publishing this notice of that
Nominations received after August 14, II. Criteria for Voting Members
determination as required by law. FDA
2017, will be considered for nomination The committee consists of a core of 15 has made the determination because of
to the committee as later vacancies members, including the Chair. Members the submission of applications to the
occur. and the Chair are selected by the Director of the U.S. Patent and
ADDRESSES: All nominations for Commissioner or designee from among Trademark Office (USPTO), Department
membership should be submitted physicians, practitioners, and other of Commerce, for the extension of a
electronically by logging into the FDA health professionals, whose clinical patent which claims that medical
Advisory Nomination Portal: http:// practice, research specialization, or device.
www.accessdata.fda.gov/scripts/ professional expertise includes a
significant focus on mammography. DATES: Anyone with knowledge that any
FACTRSPortal/FACTRS/index.cfm or by of the dates as published (see the
mail to Advisory Committee Oversight Almost all non-Federal members of this
SUPPLEMENTARY INFORMATION section) are
and Management Staff, Food and Drug committee serve as Special Government
Employees. Members will be invited to incorrect may submit either electronic
Administration, 10903 New Hampshire or written comments and ask for a
Ave., Bldg. 32, Rm. 5103, Silver Spring, serve for terms of up to 4 years.
redetermination by August 14, 2017.
MD 20993–0002. Information about III. Nomination Procedures Furthermore, any interested person may
becoming a member on an FDA advisory Any interested person may nominate petition FDA for a determination
committee can also be obtained by one or more qualified persons for regarding whether the applicant for
visiting FDA’s Web site at http:// membership on the advisory committee. extension acted with due diligence
mstockstill on DSK30JT082PROD with NOTICES

www.fda.gov/AdvisoryCommittees/ Self-nominations are also accepted. during the regulatory review period by
default.htm. Nominations must include a current, December 11, 2017. See ‘‘Petitions’’ in
FOR FURTHER INFORMATION CONTACT: complete resume or curriculum vitae for the SUPPLEMENTARY INFORMATION section
Regarding all nomination questions for each nominee, including current for more information.
membership: Sara Anderson, Center for business address and/or home address, ADDRESSES: You may submit comments
Devices and Radiological Health, Food telephone number, and email address if as follows. Please note that late,
and Drug Administration, 10903 New available. Nominations must specify the untimely filed comments will not be

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Document Created: 2017-06-14 01:24:01
Document Modified: 2017-06-14 01:24:01

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 14, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 11, 2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
Contact		Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation		82 FR 27266

82 FR 27266 - Determination of Regulatory Review Period for Purposes of Patent Extension; NEUROPACE RNS SYSTEM

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 113 (June 14, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration